FDA.report

Exalt ™

Primary DI
00191506007935
Brand
Exalt ™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0054278R0
Catalog number
M0054278R0
Device description
Monitor
Published
2021-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EOQBronchoscope (flexible or rigid)

Product Code Classifications

CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00191506007935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506007935001915060079351915060079350191506007935

GMDN Terms

TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods

Method

Regulatory Flags

DUNS number
021717889
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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